肿瘤细胞治疗研究
英文原题：Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer
这是一项 I/II 期注册临床试验，评估细胞治疗用于卵巢癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 42 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT07589543。
仅女性 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： • 年龄18至75岁，能够提供书面知情同意。 • 组织学确诊上皮性卵巢癌、输卵管癌或原发性腹膜癌；标准治疗后复发或难治（至少接受过2种既往全身治疗方案）；符合RECIST v1.1的可测量疾病，ECOG体能状态0至1。 • 有可用于抗原评估的肿瘤组织。受试者须符合方案规定的所选双靶点组合阳性标准（例如一个靶点在≥50%的肿瘤细胞中表达，另一个靶点在≥20%的肿瘤细胞中表达，IHC检测）。 • 按方案规定实验室标准达到足够器官功能；妊娠试验阴性，并同意在输注后方案规定期限内采取有效避孕措施。 排除标准： • 活动性中枢神经系统转移或癌性脑膜炎（经治疗且在方案规定期间内稳定者除外）。 • 过去6个月内接受过靶向研究抗原（GD2、MUC1、PSMA、间皮素）的基因修饰细胞治疗。 • 未控制的活动性感染（包括未控制的HIV、HBV或HCV感染）或活动性全身真菌感染。 • 有临床意义的心血管疾病（如近期心肌梗死、不稳定型心绞痛、未控制的心律失常）或LVEF<50%。 • 淋巴细胞清除前14天内存在需全身免疫抑制治疗的活动性自身免疫病（生理剂量激素替代治疗允许）。 • 有器官移植或异基因造血干细胞移植史。 • 妊娠或哺乳期。 • 研究者判断可能危及受试者安全或影响依从性的任何情况。
Inclusion Criteria: * Age 18-75 years; able to provide written informed consent. * Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that is recurrent or refractory after standard therapy (at least 2 prior systemic regimens), with measurable disease per RECIST v1.1 and ECOG performance status 0-1. * Tumor tissue available for antigen assessment. Participant must meet protocol-defined positivity for the selected dual-target pair (example: 1 target expressed in \>=50% of tumor cells by IHC and the second target in \>=20%). * Adequate organ function per protocol-specified labs; negative pregnancy test nd agrees to use effective contraception for a protocol-defined period after infusion. Exclusion Criteria: * Active CNS metastases or carcinomatous meningitis (unless treated and stable for a protocol-defined period). * Prior gene-modified cell therapy targeting any of the study antigens (GD2, MUC1, PSMA, mesothelin) within 6 months. * Uncontrolled active infection (including uncontrolled HIV, HBV, or HCV) or active systemic fungal infection. * Clinically significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia) or LVEF \<50% . * Active autoimmune disease requiring systemic immunosuppression within 14 days prior to lymphodepletion (physiologic steroid replacement permitted). * History of organ transplantation or allogeneic hematopoietic stem cell transplantation. * Pregnant or breastfeeding. * Any condition that, in the investigator's judgment, would compromise participant safety or compliance.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Incidence of dose-limiting toxicities (DLTs) to determine maximum tolerated dose (MTD) · 28 days；Incidence, severity, and relatedness of adverse events (AEs) · 28 days
次要终点：Objective response rate (ORR) per RECIST v1.1.；Overall survival (OS)
本研究评估双靶点嵌合抗原受体自然杀伤细胞（CAR-NK）疗法EB-DUALNK用于复发或难治性上皮性卵巢癌成人患者的安全性、耐受性和初步抗肿瘤活性。候选靶点包括GD2、MUC1、PSMA和间皮素。基线生物标志物评估（肿瘤抗原表达）后，将选择最合适的双靶点组合开展临床研究。参与者接受淋巴细胞清除化疗，随后输注EB-DUALNK，并接受安全性和疗效随访。
This study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. After baseline biomarker assessment (tumor antigen expression), the program will select the most suitable dual-target pair for clinical testing. Participants will receive lymphodepleting chemotherapy followed by EB-DUALNK infusion and safety/response follow-up.
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